Melanoma Clinical Trial
Photodynamic Therapy for Prevention of Nonmelanoma Skin Cancer in Organ Transplant Recipients
Summary
The study will draw patients from the Transplant Dermatology specialty clinic, where the investigators see organ transplant recipients (OTR) for regular screening and serve as a regional referral center for this population. Enrollment will be limited to 20 patients. Inclusion criteria are organ transplant recipients status, active immunosuppression for at least 5 years, and history of at least one NMSC.
Full Description
Patients will receive Levulan Kerastick (aminolevulinic acid) to the face and/or scalp (if both are needed, treated separately on back to back days); incubation: 2.5 hours and blue light photodynamic therapy utilizing the DUSA BLU-U device; illumination: 1000 seconds (16 min, 40 secs); administered quarterly for 3 years. Patients who change systemic immunosuppression regimens or add or increase systemic chemoprevention while in the study will be excluded from the overall analysis. The patients will be evaluated by the principal investigator every 3 months, prior to photodynamic therapy (PDT) administration.
Primary endpoints include:
development of non melanoma skin cancers (NMSC) lesions and
assessment of actinic damage score.
The primary endpoint will be development of new skin cancers at 3 years, based on comparison to rate at baseline from previous (x) year(s) using absolute slope value for number prior to treatment vs. number after treatment. The patients will serve as their own controls and the investigators will analyze the delta in development of non melanoma skin cancers and actinic damage score pre- and post- treatment.
Additionally, an actinic damage score will be assigned based on the number of actinic keratosis on initial evaluation. At each 3 month follow up visit, the actinic damage score will be reassessed. The investigators will be able to secondarily analyze the delta in the actinic damage score on treatment.
Eligibility Criteria
Inclusion Criteria:
The patient has been the recipient of any solid organ transplant.
Active immunosuppression for at least 5 years
History of at least one NMSC
Subject is willing to sign an informed consent to participate in this study.
Exclusion Criteria:
Patient is not appropriate candidate for treatment or research trial per treating physician
Patient has a mental health condition that makes them unable to participate in this research trial, per PI judgment.
Patient is on additional immunosuppression for diagnosis unrelated to organ transplant -
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Fairfax Virginia, 22031, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.